Autism Spectrum DisorderHEARTS-R34NCT05608083
HEARTS R34 Feasibility Study, Autistic Participants
A study testing HEARTS classes and Online discussion group in people with Autism Spectrum Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- HEARTS classes and Online discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with autism by a healthcare provider or other professional
- Willing to be randomized to either HEARTS or the active control condition (ACC)
- Have not already participated in the study, nor in the HEARTS class previously
- English speaking
Who cannot join
- unwilling or unable to provide informed consent by themselves
- have participated at any time previously in HEARTS research or the HEARTS class
- are unable to understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement
The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings.
Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys.
- Conditions
- Autism Spectrum Disorder
- Being tested
- HEARTS classes, Online discussion group
- Keywords
- Friendships, Dating relationships, Zoom sessions, Satisfaction
- Medical subject headings
- Autism Spectrum Disorder, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARTS classesBehavioural
HEARTS teaches autistic adults about friendship and healthy dating relationships. HEARTS is 6-sessions long and meets weekly over zoom. Each session is 90 minutes long.
Online discussion groupBehavioural
A 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults.
| Study group | Role | What they receive |
|---|---|---|
| HEARTS NOW | Experimental | Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships. Receives: Behavioral: HEARTS classes |
| HEARTS LATER | Active comparator | Participants in the HEARTS LATER group will participate in a six-week online support group via Zoom about relationships. Participants in this arm will have the option of taking the HEARTS class after the study has ended. Receives: Behavioral: Online discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hostile Automatic Thoughts (HATS)
The 25-item Hostile Automatic Thoughts (HAT) Scale is a self-report measure that assesses participants' ability to engage in perspective-taking related to perceived rejection and the extent to which they attribute hostile intentions to a person given an ambiguous situation. Completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. Scale minimum possible score of 25, scale maximum possible score of 125. A higher score is less desirable and indicates more Hostile Automatic Thoughts.
Measured: baseline, 12 weeks
Rejection Sensitivity Questionnaire
The Rejection Sensitivity Questionnaire (RSQ), a 10-item self-report measure that assesses participants' capacity to be resilient when experiencing social rejection such as sending a text message and not getting a reply. Lower scores are associated with more resilience given rejection and thus are desirable. The minimum possible score is 20 and the maximum possible score is 720.
Measured: baseline, 12 weeks
CGI-I
This was a binary variable that represents either improvement, or no improvement. To assess improvement, we used the Clinical Global Impressions-Improvement (CGI-I) which is a global measure of improvement and functioning, and measures satisfaction with quality of close relationships. Each of the 3 items are rated on a 7-point scale from: 1 (normal) to 7 (amongst the most severely ill patients). CGI-C scores range from 7 (very much worse) to 1 (very much improved). In this study, those who scored 1, 2 or 3 were considered "improved" and those who scored 4, 5, 6 or 7 were considered "not improved."
Measured: baseline, 12 weeks
SMI
Social motivation was assessed via the Autistic Social Health Interview. The ASHI, adapted from the Social Motivation Interview (Elias \& White, 2020), assesses the following dimensions of social health: person's satisfaction with their interpersonal relationships, motivation to socialize, quantity of social relationships and encounters, and willingness to persist in social interaction. During the interview, the interviewer enquires about behaviors over the prior two weeks. The total ASHI score can range from 0-24, with higher scores indicative of greater overall social health.
Measured: baseline, 12 weeks
Secondary outcomes (3)
Intervention Acceptability
An investigator developed self report 3-item scale to assess participants' feelings about whether HEARTS was informative, interesting, how likely participants would be to recommend it to other people and suggestions for how it could be improved will be used to assess this outcome. Participants will indicate their satisfaction on a scale from 1 to 10, where 10 represents highest satisfaction.
Measured: 6 weeks
Content Acceptability, Week 1
This is an original measure with no scale name and with no subscales that assesses acceptability of intervention content. It is 29 items. Each item asks the participant how useful they found a piece of intervention content. Responses range from 1 to 10 with 1 representing "not at all useful" and 10 representing "very useful." The measure is scored by calculating the average across the items for a given week (Week 1, 3 items; Week 2, 6 items; Week 3, 4 items; Week 4, 6 items; Week 5, 5 items; Week 6, 5 items). The six scores representing each week are then averaged together for a total score. The total score range is 1 to 10.
Measured: weekly during the 6 weeks of the interventions
Teacher Rating of Participant Engagement and Satisfaction
Teachers of the HEARTS intervention will complete a 3-item survey to assess their rating of participant engagement and satisfaction scores (PESS). Scores can range from 0 to 3 where 0 is low and 3 is high satisfaction. Higher scores are more favorable.
Measured: weekly during the 6 weeks of the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Rothman, Boston University Charles River Campus
- Investigators
- Emily F Rothman, ScD, Principal investigator, BU Sargent College, Occupational Therapy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608083
- Sponsor's protocol ID
- 6800E
- Acronym
- HEARTS-R34
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2022
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement
- ClinicalTrials.gov ID
- NCT05608083
- Acronym / sponsor ID
- HEARTS-R34 / 6800E
- Conditions
- Autism Spectrum Disorder
- Keywords
- Friendships, Dating relationships, Zoom sessions, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Alabama at Birmingham
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings.
Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEARTS NOW | Experimental | Behavioral: HEARTS classesParticipants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships. |
| HEARTS LATER | Active comparator | Behavioral: Online discussion groupParticipants in the HEARTS LATER group will participate in a six-week online support group via Zoom about relationships. Participants in this arm will have the option of taking the HEARTS class after the study has ended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with autism by a healthcare provider or other professional
- Willing to be randomized to either HEARTS or the active control condition (ACC)
- Have not already participated in the study, nor in the HEARTS class previously
- English speaking
Key exclusion criteria (3 listed)
- unwilling or unable to provide informed consent by themselves
- have participated at any time previously in HEARTS research or the HEARTS class
- are unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEARTS classesHEARTS teaches autistic adults about friendship and healthy dating relationships. HEARTS is 6-sessions long and meets weekly over zoom. Each session is 90 minutes long. | Behavioural | HEARTS NOW |
| Online discussion groupA 90-minute discussion group will meet online weekly for 6 weeks to discuss friendships and healthy dating relationships for autistic adults. | Behavioural | HEARTS LATER |
Primary outcome
Hostile Automatic Thoughts (HATS)
Time frame: baseline, 12 weeks
The 25-item Hostile Automatic Thoughts (HAT) Scale is a self-report measure that assesses participants' ability to engage in perspective-taking related to perceived rejection and the extent to which they attribute hostile intentions to a person given an ambiguous situation. Completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. Scale minimum possible score of 25, scale maximum possible score of 125. A higher score is less desirable and indicates more Hostile Automatic Thoughts.
Rejection Sensitivity Questionnaire
Time frame: baseline, 12 weeks
The Rejection Sensitivity Questionnaire (RSQ), a 10-item self-report measure that assesses participants' capacity to be resilient when experiencing social rejection such as sending a text message and not getting a reply. Lower scores are associated with more resilience given rejection and thus are desirable. The minimum possible score is 20 and the maximum possible score is 720.
CGI-I
Time frame: baseline, 12 weeks
This was a binary variable that represents either improvement, or no improvement. To assess improvement, we used the Clinical Global Impressions-Improvement (CGI-I) which is a global measure of improvement and functioning, and measures satisfaction with quality of close relationships. Each of the 3 items are rated on a 7-point scale from: 1 (normal) to 7 (amongst the most severely ill patients). CGI-C scores range from 7 (very much worse) to 1 (very much improved). In this study, those who scored 1, 2 or 3 were considered "improved" and those who scored 4, 5, 6 or 7 were considered "not improved."
SMI
Time frame: baseline, 12 weeks
Social motivation was assessed via the Autistic Social Health Interview. The ASHI, adapted from the Social Motivation Interview (Elias \& White, 2020), assesses the following dimensions of social health: person's satisfaction with their interpersonal relationships, motivation to socialize, quantity of social relationships and encounters, and willingness to persist in social interaction. During the interview, the interviewer enquires about behaviors over the prior two weeks. The total ASHI score can range from 0-24, with higher scores indicative of greater overall social health.
3 secondary outcomes
Intervention Acceptability
Time frame: 6 weeks
Content Acceptability, Week 1
Time frame: weekly during the 6 weeks of the interventions
Teacher Rating of Participant Engagement and Satisfaction
Time frame: weekly during the 6 weeks of the interventions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily F Rothman, ScD principal investigator
BU Sargent College, Occupational Therapy Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEARTS classes and Online discussion group in people with Autism Spectrum Disorder, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hostile Automatic Thoughts (HATS) (time frame: baseline, 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.